Skip to contentApplication 020313
- Type
- NDA
- Sponsor
- MYLAN IRELAND LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 002 | MIACALCIN | CALCITONIN SALMON | SPRAY, METERED;NASAL | 200 IU/SPRAY | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0781-6320 | calcitonin salmon | calcitonin salmon | Sandoz Inc | NDA AUTHORIZED GENERIC | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 49758 | SUPPL | 2017-09-15 |
| 49728 | SUPPL | 2017-09-13 |
| 24767 | SUPPL | 2014-03-13 |
| 12439 | SUPPL | 2014-03-13 |
| 23576 | ORIG | 2014-03-12 |
| 24766 | SUPPL | 2012-04-23 |
| 34497 | SUPPL | 2012-04-20 |
| 34496 | SUPPL | 2009-12-10 |
| 20595 | SUPPL | 2007-07-06 |
| 24765 | SUPPL | 2006-01-20 |
| 2325 | SUPPL | 2003-08-28 |